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Captopril for Radiation-Induced Pulmonary Damage in Lung Cancer
NCT00077064Phase 2
Key facts
- Status
- Terminated
- Start
- Jun 2003
- Primary completion
- Nov 2008
- Countries
- 1
- Sponsor
- NRG Oncology
- Modality
- Small Molecules
- Drugs
- captopril
- Conditions
- pulmonary fibrosis (PF)
01
Overview
Phase 2, randomised, open-label trial in pulmonary fibrosis (PF) comparing Captopril with Observation (2 arms). Primary endpoint: Incidence of Therapy-induced Lung Toxicity at 12 months. Started Jun 2003; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Captopril
Oral captopril 3 times daily for 1 year.
Observation
Observation only for 1 year.
03
Who it enrols
Patients with Stage II-IIIB NSCLC, Stage I central NSCLC, or limited-stage SCLC planning to receive radiotherapy (>45 Gy). Must have adequate hematopoietic, hepatic, and renal function. Excludes patients on concurrent ACE inhibitors, lithium, or procainamide.
04
Endpoints
Primary
Incidence of Therapy-induced Lung Toxicity
Secondary
Correlation of Lung Toxicities With Biochemical Markers
Correlation of Quality of Life With Late Effects
Persistence of Pulmonary Toxicity at 2 Years After Completion of Study Treatment
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